Implementing Single Use Technologies in Sterile Vaccines Processing

This on-demand webinar presented by Charlotte Masy of GSK is a case study illustration of GSK’s strategic approach for sterility assurance.

One of the main challenges when considering single-use technologies in sterile vaccines manufacturing is to ensure the highest level of assurance of integrity and sterility.

 

This webinar presented by Charlotte Masy of GSK is a case study illustration of GSK’s strategic approach for sterility assurance.

 

 Topics covered:

 

  • How a Quality by Design (QbD) approach has been applied to develop, design and qualify single-use systems for vaccine manufacturing
  • How GSK manage sterility assurance concerns
  • Assessing and mitigating risks to integrity of SUS in sterile applications

 

Speaker

 

 

Charlotte Masy

Charlotte Masy

 

Technical Lifecycle Project Manager 

TLCM-MSAT

GlaxoSmithKline

Learn more about the Helium Integrity Test

Manage risk in your critical process with this high sensitivity, supplier integrity test for single-use systems, filling sets and mixer biocontainers

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September 2020

With the publication of the new chapters in USP <665> due in September join Ken Wong from Sanofi Pasteur, Desmond Hunt from United States Pharmacopeia and James Hathcock from Pall Biotech to get the latest updates.

Participants will learn:

  • About the USP <665> standardized extraction solution protocol for manufacturing components and systems
  • What is new and what has changed in USP <665> and <1665> (as of September 2020)
  • The top issues influencing the alignment of the BioPhorum extractables protocol and USP <665>
  • What level of data end-users can expect to see
  • How to apply USP <665> data sets to support risk assessment and qualification of single-use systems
  • The opportunities ahead for simplifying the adoption of single-use technologies

 

Don’t miss this free BioPharma Asia webinar to hear from subject matter experts serving on the USP and BPOG panels!

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